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acufex metal acl cannula
Acufex Microsurgical
Summary: The Acufex Metal ACL Cannula is a surgical instrument used primarily in orthopedic procedures, specifically for ACL reconstruction. It is typically used by orthopedic surgeons in operating rooms.
FDA Clearance Information
Pathway
510K
Number
K932718 ↗
Decision Date
March 21, 1994
Product Code
HRX
Device Class
Class 2
Evidence
0 studies
The Acufex Metal ACL Cannula was cleared through the FDA 510(k) pathway on March 21, 1994. It is manufactured by Acufex Microsurgical and is classified as a Class 2 device under product code HRX.
What It Is
The Acufex Metal ACL Cannula is a specialized surgical tool designed for use in anterior cruciate ligament (ACL) reconstruction surgeries. It facilitates the precise placement of grafts by allowing surgeons to guide surgical instruments and suture materials through the knee joint. Made of durable metal, it is designed to withstand the rigors of surgical procedures and ensure accuracy and efficiency in ligament repair.
Clinical Applications
This device is commonly used in orthopedic surgeries, particularly in sports medicine, where ACL injuries are prevalent. It is utilized in hospital operating rooms and outpatient surgical centers. The primary patient population includes athletes and individuals with ACL tears requiring surgical intervention for ligament reconstruction.
Indications for Use
The FDA-cleared indications for the Acufex Metal ACL Cannula involve its use in ACL reconstruction surgeries. It is intended for patients with ACL injuries, typically those who have experienced ligament tears due to sports or traumatic injuries.
Practical Considerations
The Acufex Metal ACL Cannula comes in various sizes to accommodate different patient anatomies and surgical techniques. It is compatible with standard surgical instruments used in ACL reconstruction. Surgeons should be familiar with its handling and integration into the surgical workflow to optimize outcomes.
Frequently Asked Questions
What is the Acufex Metal ACL Cannula used for?
The Acufex Metal ACL Cannula is used for guiding instruments and sutures during ACL reconstruction surgeries.
What specialties typically use this device?
Orthopedic surgeons, particularly those specializing in sports medicine, commonly use this device.
What are the FDA-cleared indications?
The device is indicated for use in ACL reconstruction surgeries for patients with ligament injuries.
Disclaimer: This page compiles publicly available regulatory and published clinical evidence for educational reference.
It does not constitute medical advice, product endorsement, or a recommendation for clinical use.
Always consult manufacturer documentation and clinical judgment for patient care decisions.